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Summary

for people ages 50–85 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog 13], and AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) [ADCS-ADL-MCI].

Official Title

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects With Early Alzheimer's Disease

Keywords

Alzheimer's Disease BIIB037 Aducanumab

Eligibility

For people ages 50–85

Key Inclusion Criteria:

  • Must meet all of the following clinical criteria for MCI due to AD or mild AD and must have:
  • A Clinical Dementia Rating (CDR)-Global Score of 0.5.
  • Objective evidence of cognitive impairment at screening
  • An MMSE score between 24 and 30 (inclusive)
  • Must have a positive amyloid Positron Emission Tomography (PET) scan
  • Must consent to apolipoprotein E (ApoE) genotyping
  • If using drugs to treat symptoms related to AD, doses must be stable for at least 8 weeks prior to screening visit 1
  • Must have a reliable informant or caregiver

Key Exclusion Criteria:

  • Any medical or neurological condition (other than Alzheimer's Disease) that might be a contributing cause of the subject's cognitive impairment
  • Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year
  • Clinically significant unstable psychiatric illness in past 6 months
  • History of unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within 1 year prior to Screening
  • Indication of impaired renal or liver function
  • Have human immunodeficiency virus (HIV) infection
  • Have a significant systematic illness or infection in past 30 days
  • Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
  • Any contraindications to brain magnetic resonance imaging (MRI) or PET scans
  • Alcohol or substance abuse in past 1 year
  • Taking blood thinners (except for aspirin at a prophylactic dose or less)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Locations

  • Southern California Research LLC accepting new patients
    Simi Valley, California, 93065, United States
  • California Neuroscience Research Medical Group Inc. accepting new patients
    Sherman Oaks, California, 91403, United States
  • Torrance Clinical Research Institute, Inc. in progress, not accepting new patients
    Lomita, California, 90717, United States
  • University of California - Los Angeles accepting new patients
    Los Angeles, California, 90095, United States
  • Neurology Center of North Orange County accepting new patients
    Fullerton, California, 92835, United States
  • Senior Clinical Trials, Inc. accepting new patients
    Laguna Hills, California, 92653, United States
  • Las Vegas Medical research accepting new patients
    Las Vegas, Nevada, 89113, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Biogen
Links
US Residents may click here to find out more about participation in this trial
ID
NCT02477800
Phase
Phase 3
Lead Scientist
Adam Boxer
Study Type
Interventional
Last Updated
August 1, 2017
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